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Aripiprazole Tablets, USP 20 mg, packaged in a) 1,000-count bottle (NDC 60505-2676-8, UPC 3 6050...

FDA Recall #D-1285-2022 — Class II — July 7, 2022

Recall #D-1285-2022 Date: July 7, 2022 Classification: Class II Status: Terminated

Product Description

Aripiprazole Tablets, USP 20 mg, packaged in a) 1,000-count bottle (NDC 60505-2676-8, UPC 3 60505 26768 2), b) 30-count bottle (NDC 60505-2676-3, UPC 3 60505 26763 7), Rx only, Manufactured by: Apotex, Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326

Reason for Recall

Failed dissolution specifications: OOS for dissolution at the 12-month stability time point.

Recalling Firm

Apotex Corp. — Weston, FL

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

2010 bottles

Distribution

USA Nationwide

Code Information

Lots: a) TD9591 Exp. 04/2023; b) TD9592 Exp. 04/2023

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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